Pub Date : 2021-01-01DOI: 10.1080/01947648.2021.1935633
Brittney M Welch
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Pub Date : 2021-01-01DOI: 10.1080/01947648.2021.1917464
Austin Connor Kassels, Jon F Merz
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would "destroy or invalidate" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.
{"title":"The History and Policy Evolution of Waivers of Informed Consent in Research.","authors":"Austin Connor Kassels, Jon F Merz","doi":"10.1080/01947648.2021.1917464","DOIUrl":"https://doi.org/10.1080/01947648.2021.1917464","url":null,"abstract":"<p><p>We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would \"destroy or invalidate\" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2021.1917464","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39211974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-11-02DOI: 10.1080/01947648.2020.1826875
Isaac D. Buck Reviewed by
Health law and policy scholars are naturally motivated to improve the American health care system, which is defined by poor quality metrics, racial and socioeconomic disparities, and exorbitant cos...
{"title":"Exposed: Why Health Insurance Is Incomplete and What Can Be Done about It: Christopher T. Robertson (Harvard University Press, 2019, 248 pp.)","authors":"Isaac D. Buck Reviewed by","doi":"10.1080/01947648.2020.1826875","DOIUrl":"https://doi.org/10.1080/01947648.2020.1826875","url":null,"abstract":"Health law and policy scholars are naturally motivated to improve the American health care system, which is defined by poor quality metrics, racial and socioeconomic disparities, and exorbitant cos...","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76838965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-10-01DOI: 10.1080/01947648.2020.1856568
Erin C Fuse Brown
In the midst of an historic election, with the Supreme Court considering another existential challenge to the Affordable Care Act (ACA) and with the nation plunged into a public health and economic crisis from the 2020 coronavirus pandemic, the ACA is as important as ever. The ACA matters. It matters to many millions who count on its protections to access health coverage, particularly as they lose their job-based insurance in the pandemic. It matters to voters and to their representatives tasked with the next generation of health reform. It matters to states, the health care industry, and businesses who have sunk innumerable resources and time into making the ACA work. The Trillion Dollar Revolution assesses the ACA at 10 years, marking its achievements, trade-offs, shortfalls, impacts, and lessons for future reforms. The ACA was both monumental and paradoxical. It was the single biggest social welfare legislation enacted in 50 years and touched every aspect of our sprawling health care system. Yet the narrow political window for its passage meant that the ACA was incremental, building on, rather than fundamentally restructuring, our fragmented health care system. The ACA was imperfect because it inherited many flaws of the existing health care system. Nevertheless, the ACA achieved something quite revolutionary—it changed the minds of the American public, who have since embraced notions of health care access as a right and preexisting condition protections as a given. Edited by Ezekiel Emanuel and Abbe Gluck, the book reads like an insider’s account and assessment of the ACA. The contributors are a veritable Who’s Who of lawyers, health law scholars, health economists, health policy experts, and political leaders with a front-row view of the ACA. Divided into five parts, the essays discuss the ACA’s (I) policy goals, (II) implementation, (III) legal challenges, (IV) impacts, and (V) lessons for the future. The book is well suited for health law and policy students in college or graduatelevel courses, as well as for academics, journalists, health policymakers, and wonks. Fittingly, the book opens with a chapter by Timothy Stoltzfus Jost and John McDonough, perhaps the two most knowledgeable individuals in the country about the law and policy of the ACA. This chapter could stand by itself for its concise history of the ACA, what drove it, what it did, what worked, and what it did not do. Historians and policy scholars will appreciate the first-person accounts of the difficult trade-offs in passage and challenges of implementation by those who were in the room where it happened, including Kathleen Sebelius, who was the Secretary of Health & Human Services for the passage and implementation; Nancy-Ann DePearle, senior health policy advisor to President Obama; Peter Orszag, the director of the Office of
{"title":"The Trillion Dollar Revolution: How the Affordable Care Act Transformed Politics, Law, and Health Care in America","authors":"Erin C Fuse Brown","doi":"10.1080/01947648.2020.1856568","DOIUrl":"https://doi.org/10.1080/01947648.2020.1856568","url":null,"abstract":"In the midst of an historic election, with the Supreme Court considering another existential challenge to the Affordable Care Act (ACA) and with the nation plunged into a public health and economic crisis from the 2020 coronavirus pandemic, the ACA is as important as ever. The ACA matters. It matters to many millions who count on its protections to access health coverage, particularly as they lose their job-based insurance in the pandemic. It matters to voters and to their representatives tasked with the next generation of health reform. It matters to states, the health care industry, and businesses who have sunk innumerable resources and time into making the ACA work. The Trillion Dollar Revolution assesses the ACA at 10 years, marking its achievements, trade-offs, shortfalls, impacts, and lessons for future reforms. The ACA was both monumental and paradoxical. It was the single biggest social welfare legislation enacted in 50 years and touched every aspect of our sprawling health care system. Yet the narrow political window for its passage meant that the ACA was incremental, building on, rather than fundamentally restructuring, our fragmented health care system. The ACA was imperfect because it inherited many flaws of the existing health care system. Nevertheless, the ACA achieved something quite revolutionary—it changed the minds of the American public, who have since embraced notions of health care access as a right and preexisting condition protections as a given. Edited by Ezekiel Emanuel and Abbe Gluck, the book reads like an insider’s account and assessment of the ACA. The contributors are a veritable Who’s Who of lawyers, health law scholars, health economists, health policy experts, and political leaders with a front-row view of the ACA. Divided into five parts, the essays discuss the ACA’s (I) policy goals, (II) implementation, (III) legal challenges, (IV) impacts, and (V) lessons for the future. The book is well suited for health law and policy students in college or graduatelevel courses, as well as for academics, journalists, health policymakers, and wonks. Fittingly, the book opens with a chapter by Timothy Stoltzfus Jost and John McDonough, perhaps the two most knowledgeable individuals in the country about the law and policy of the ACA. This chapter could stand by itself for its concise history of the ACA, what drove it, what it did, what worked, and what it did not do. Historians and policy scholars will appreciate the first-person accounts of the difficult trade-offs in passage and challenges of implementation by those who were in the room where it happened, including Kathleen Sebelius, who was the Secretary of Health & Human Services for the passage and implementation; Nancy-Ann DePearle, senior health policy advisor to President Obama; Peter Orszag, the director of the Office of","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78000962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-10-01DOI: 10.1080/01947648.2020.1856567
A. English
Preventing Child Trafficking: A Public Health Approach, published in 2019, is written by two experts on human trafficking of children: Jonathan Todres, Distinguished University Professor at Georgia State University College of Law, and Angela Diaz, professor of adolescent health at the Icahn School of Medicine and director of the Mount Sinai Adolescent Health Center in New York City. Since the book’s publication, the world has changed dramatically, with the emergence in 2020 of the COVID-19 pandemic and the increased visibility of rampant, systemic racism. These developments underscore the importance of the central message of Preventing Child Trafficking—that prevention must be prioritized in addressing human trafficking of children and that a public health approach is essential in doing so. The authors make their case methodically, with a detailed review of laws, policies, and programs; careful attention to the burgeoning body of relevant evidence; and useful real-life illustrations drawn from their extensive experience with children and adolescents who have been trafficked. At the outset, Todres and Diaz provide useful discussion of terminology, definitions, and the focus of the book. This discussion highlights important issues. For example, use of the word “child” in the title and throughout the book has both advantages and drawbacks. Its use is consistent with terminology in international treaties, U.S. laws, and many official policies and reports. In that context, it refers to individuals under the age of 18 years. This usage is also reflected in a growing concern about exploitation of “children,” not only among policymakers but also on the part of the public. At the same time, as the authors acknowledge, the 18th birthday is often irrelevant when examining who is trafficked. The reality is that many “adolescents,” “youth,” and “young adults” who are over the age of 18 are trafficked and exploited in the same ways as younger children and adolescents who not yet age 18. Even though the terminology does not correspond to legal definitions, addressing the needs of these age groups is just as important when implementing a public health approach to trafficking. The focus of Preventing Child Trafficking, as the authors explain, is primarily on sex trafficking. This foregoes an opportunity to do a deeper exploration of the intersection of sex and labor trafficking and of public health implications and potential with respect to labor trafficking. Addressing forced labor and labor trafficking is an essential component of an effective public health approach to trafficking for several reasons. The risk factors and root causes are similar to those of sex trafficking, and the adverse health consequences are also similar in both nature and severity. The authors acknowledge this and do a good job of highlighting the specific ways in which human trafficking touches all of us—in the clothes and other products we buy, the food we eat—many of which involve forc
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Pub Date : 2020-10-01DOI: 10.1080/01947648.2020.1856569
E. Segall
Professor Mary Ziegler is the author of three books on abortion. Her latest book, Abortion and the Law in America: Roe v. Wade to the Present, like the first two, makes major contributions to the unfortunately divisive debates about women’s right to control their reproductive choices and the concerns of millions of Americans for the fetuses killed when women exercise those rights. Readers will not uncover Ziegler’s personal views on abortion when reading this book, which is just one of the many strengths of this wonderful new treatment of a very old topic. Talking about abortion is truly difficult in our polarized country. I once wrote the following:
{"title":"Abortion and the Law in America: Roe v. Wade to the Present","authors":"E. Segall","doi":"10.1080/01947648.2020.1856569","DOIUrl":"https://doi.org/10.1080/01947648.2020.1856569","url":null,"abstract":"Professor Mary Ziegler is the author of three books on abortion. Her latest book, Abortion and the Law in America: Roe v. Wade to the Present, like the first two, makes major contributions to the unfortunately divisive debates about women’s right to control their reproductive choices and the concerns of millions of Americans for the fetuses killed when women exercise those rights. Readers will not uncover Ziegler’s personal views on abortion when reading this book, which is just one of the many strengths of this wonderful new treatment of a very old topic. Talking about abortion is truly difficult in our polarized country. I once wrote the following:","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84654649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-28DOI: 10.1080/01947648.2020.1833656
L. Price, Sarah E. Fagan, Joseph P. Hardy
In response to the large number of opioid prescriptions and the perceived opioid crisis, numerous states, including Nevada, responded by imposing mandates on physicians’ prescribing practices for t...
{"title":"Investigating the Relationship Between Opioid Prescription Frequency and Deaths from Illicit Opioids","authors":"L. Price, Sarah E. Fagan, Joseph P. Hardy","doi":"10.1080/01947648.2020.1833656","DOIUrl":"https://doi.org/10.1080/01947648.2020.1833656","url":null,"abstract":"In response to the large number of opioid prescriptions and the perceived opioid crisis, numerous states, including Nevada, responded by imposing mandates on physicians’ prescribing practices for t...","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91026808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-28DOI: 10.1080/01947648.2020.1833669
T. Green, J. Demay, Tabitha Sierra, K. Zucker, C. Unsworth
Health insurance is complex and greatly affects healthcare delivery in the United States. Risk pooling and limited resources create ethical challenges on how to distribute care and determine covere...
{"title":"The Ethical Issues of Healthcare Insurance Coverage","authors":"T. Green, J. Demay, Tabitha Sierra, K. Zucker, C. Unsworth","doi":"10.1080/01947648.2020.1833669","DOIUrl":"https://doi.org/10.1080/01947648.2020.1833669","url":null,"abstract":"Health insurance is complex and greatly affects healthcare delivery in the United States. Risk pooling and limited resources create ethical challenges on how to distribute care and determine covere...","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74485709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-28DOI: 10.1080/01947648.2020.1833671
M. DeSanto, A. M. Weaver, R. Bitonte
In the midst of the technological age, many groups have found another platform to express their voice and beliefs through the internet. Many individuals also look to the internet to research health...
在科技时代,许多群体通过互联网找到了另一个表达自己声音和信仰的平台。许多人还通过互联网研究健康……
{"title":"Is the Collection and Distribution of Abortion Providers’ Names and Addresses a Solicitation for Violence?","authors":"M. DeSanto, A. M. Weaver, R. Bitonte","doi":"10.1080/01947648.2020.1833671","DOIUrl":"https://doi.org/10.1080/01947648.2020.1833671","url":null,"abstract":"In the midst of the technological age, many groups have found another platform to express their voice and beliefs through the internet. Many individuals also look to the internet to research health...","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87987652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-28DOI: 10.1080/01947648.2020.1833660
M. G. Harris, R. Bitonte
Vaping was once thought of as a healthier alternative to smoking cigarettes in that the user is not inhaling burned tobacco but instead inhaling an aerosol. The vape liquid is also noted to have le...
{"title":"Class Action Litigation: an Effective Tool for Public Health Issues; Specifically Vaping and Electronic Cigarettes","authors":"M. G. Harris, R. Bitonte","doi":"10.1080/01947648.2020.1833660","DOIUrl":"https://doi.org/10.1080/01947648.2020.1833660","url":null,"abstract":"Vaping was once thought of as a healthier alternative to smoking cigarettes in that the user is not inhaling burned tobacco but instead inhaling an aerosol. The vape liquid is also noted to have le...","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90138980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}